Pluristem obtains Indian Phase II trial approval

The company will test its PLX cells for the treatment of Buerger's disease, ahead of a global Phase III trial.

16 August 12 11:49, Globes' correspondent

Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) has obtained permission from India's Ministry of Health for a Phase II clinical trial for the company's placental expanded cells for the treatment of Buerger's disease. This trial will be potentially followed by a larger multi-national Phase III study in the US, Europe, and India.

Buerger's Disease is a rare disease in which blood vessels of the hands and feet become blocked. It is highly prevalent in India, affecting 45-63% of patients who have peripheral artery disease (PAD), which afflicts an estimated 20 million people. This means that about 11 million Indians suffer from Buerger's disease. With no established treatments available, there is a strong medical need, and therefore a large market, for a treatment.

Last August, the US Food and Drug Administration (FDA) designated Pluristem's PLX cells orphan status for the treatment of Buerger's disease.

Pluristem chairman, president and CEO Zami Aberman said, "The information gathered in this trial will be a valuable step towards our goal of successfully developing a PLX cell-based product for the treatment of the entire spectrum of peripheral vascular diseases."

Pluristem's share price rose 4.4% by midday on the TASE today to NIS 17.59, after rising 3.6% on Nasdaq yesterday to $4.32, giving a market cap of $193 million.

Published by Globes [online], Israel business news - www.globes-online.com - on August 16, 2012

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